Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer

May 22, 2025 updated by: Ji Xunming,MD,PhD, Capital Medical University

Exploratory Study of the Impact of Intermittent Hypoxia Intervention on Patients With Colorectal Cancer

This study aims to explore the safety and efficacy of intermittent hypoxia intervention on patients with colorectal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The hypoxic adaptive response is a form of acquired tolerance that occurs by activating internal cellular protective mechanisms and enhancing immune function.This technology was initially utilized in sports training and high-altitude medicine to enhance strength, endurance, and overall athletic performance, as well as to enhance the body's adaptation to high-altitude hypoxia. This technology was initially utilized in sports training and high-altitude medicine to enhance strength, endurance, and overall athletic performance, as well as to enhance the body's adaptation to high-altitude hypoxia.

Intermittent hypoxia (IH) refers to periodic hypoxic-normoxic training performed with brief exposure to hypoxia. Previous studies have found that short-term intermittent hypoxia can increase the sensitivity of hypoxia and reduce the severity of acute hypoxia injury, and alleviate acute hypoxia injury by reducing the inflammatory response caused by hypoxia. Intermittent hypoxia has been shown in our team's work to effectively inhibit colorectal cancer tumor progression in mice by enhancing immune cell function. This study aims to explore the safety and efficacy of IH in patients with colorectal cancer using a non-randomized self-controlled trial.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
          • Xunming Ji, M.D.;Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with colorectal cancer between ages of 18 and 65 years.
  • Colorectal cancer stage Ⅰ,Ⅱ.
  • Subjects or their legally authorized representative can provide informed consent.

Exclusion Criteria:

  • History of cardiovascular, cerebrovascular, dermatological, and hematological diseases.
  • History of pulmonary, hepatic, kidney, dermatologic and hematologic diseases.
  • History of pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.
  • History of substance abuse.
  • Participating in other drug or medical device studies.
  • History of organ transplantation, including allogeneic stem cell and immune cell transplantation.
  • Recent severe infection within 4 weeks.
  • Received cancer treatment, including chemotherapy and radiotherapy, within 4 weeks.
  • Underwent major surgery within 28 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients
Participants will receive 14 times intermittent hypoxia (oxygen concentration: 13%) intervention before the surgery.
Other: Intermittent hypoxia intervention
The intermittent hypoxia protocol refers to 6 cycles of 10 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse reactions
Time Frame: During the 7-day treatment
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness and insomnia.
During the 7-day treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Markers
Time Frame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Blood tumor markers will be detected by the immunochemiluminescence method.
The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Tumor Change
Time Frame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Tumor Change will be detected by tumor cell HIF-1α and HIF-2α through immunohistochemistry.
The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Cytokines
Time Frame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Cytokines will be detected by immune-related cytokines in peripheral blood.
The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Symptoms
Time Frame: The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery
It is evaluated by completing the follow-up form.
The day before the 7-day treatment ; the day of surgery after the treatment;7 days after surgery
Immune Cell Infiltration
Time Frame: The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)
Immune Cell Infiltration will be detected by observation of immune cell infiltration in tumor tissue.
The day before the 7-day treatment ; the day of surgery (1-7days post the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IH-CC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe